Another fentanyl pain patch has been recalled today, amid concerns that such pain patches put users at risk of accidental fentanyl overdose.  Today’s fentanyl pain patch recall was issued by Activis Inc., which is recalling 14 lots of its Fentanyl transdermal system CII patches sold in the United States by its subsidiary Actavis South Atlantic LLC  from wholesalers and pharmacies as a precaution.  The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

Fentanyl transdermal patches are indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and that cannot be managed by other means. This is the second fentanyl pain patch recall issued in less than a week.  Last Tuesday, Johnson & Johnson recalled its 25-microgram-per-hour Duragesic Pain Patches that are sold in the U.S. by J&J’s PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp.  The defective Duragesic patches had a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.

According to the Food & Drug Administration (FDA), the 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal.  The fentanyl pain patch lots covered by the Actavis recall include: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

According to the FDA, Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the recalled fentanyl pain patches are labeled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-08.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-08.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-08.

The FDA has warned that the affected patches should not be handled directly. Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1- 877-422-7452.  Patients using fentanyl patches who have medical questions should contact their health-care providers.

This entry was posted on Monday, February 18th, 2008 at 12:07 pm and is filed under Legal News, Pharmaceuticals.